MK-2060 + Clopidogrel for Kidney Failure

No longer recruiting at 4 trial locations

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Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Merck Sharp & Dohme LLC

Must be taking: Clopidogrel

Must not be taking: Anticoagulants, Antiplatelets

Disqualifiers: Cancer, DVT, GI bleeding, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called MK-2060 to determine its safety when used with clopidogrel, a common medication, in people with end-stage renal disease (ESRD). The goal is to find out if this combination can help prevent blood clots in these patients. Suitable participants have been on dialysis for more than three months without complications and are already taking clopidogrel. As a Phase 1 trial, this research focuses on understanding how MK-2060 works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial requires that you continue taking clopidogrel, but you may need to stop other anticoagulant or antiplatelet medications, except for intradialytic heparin, which is allowed.

Is there any evidence suggesting that MK-2060 is likely to be safe for humans?

A previous study showed that MK-2060 had potential side effects, mainly related to bleeding, due to its effect on blood clotting. Researchers closely monitor these bleeding events to ensure safety. The trials have been designed to find a safe starting dose and observe any negative effects. This careful approach helps ensure the treatment's safety when tested in people. As a Phase 1 trial, the main focus is on assessing safety and evaluating how well participants tolerate the treatment. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for ESRD?

Researchers are excited about MK-2060 because it offers a new approach for patients with end-stage renal disease (ESRD) by combining it with clopidogrel, a commonly used antiplatelet drug. Unlike traditional treatments that primarily focus on dialysis or kidney transplantation, MK-2060 is an intravenous infusion that targets specific pathways to potentially enhance blood flow and reduce clotting risks. This novel mechanism could provide better safety and tolerability for patients, making it a promising option compared to existing therapies.

What evidence suggests that MK-2060 might be an effective treatment for preventing thrombotic complications in ESRD?

Research is investigating MK-2060, the investigational treatment in this trial, as a method to prevent blood clots in people with end-stage kidney disease. This drug blocks Factor XI, a protein that aids in clot formation. Earlier studies tested MK-2060 for its ability to reduce clots in specific blood vessel connections, but it did not outperform a placebo. Additionally, it increased the risk of bleeding. Despite these challenges, MK-2060 has shown potential in stopping clot formation, which might help prevent clots in people with end-stage kidney disease. ^{2 4 6 7 8}

Who Is on the Research Team?

Medical Director

Principal Investigator

Merck Sharpe & Dohme LLC

Are You a Good Fit for This Trial?

Inclusion Criteria

Has End-Stage Renal Disease (ESRD) maintained on stable outpatient hemodialysis (HD) regimen at a healthcare center for > 3 months prior to dosing.

On HD regimen at least 3 times per week for a minimum of 3 hours per dialysis session, using a complication-free well-maintained AV fistula or AV graft.

Is taking clopidogrel for a minimum of 2 weeks prior to the first dosing of MK-2060 administration.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Treatment

Participants continue their established background therapy of daily 75 mg clopidogrel for 2 weeks

2 weeks

Treatment

Participants receive 25 mg MK-2060 intravenous (IV) infusion on days 1, 3, 5, and 8 while continuing background therapy

8 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 104 days

What Are the Treatments Tested in This Trial?

Interventions

• MK-2060

How Is the Trial Designed?

Group I: MK-2060 Experimental Treatment 1 Intervention

Participants continued their established background therapy of daily 75 mg clopidogrel for 2 weeks (days -14 to 0). Participants then continued background therapy while receiving 25 mg MK-2060 intravenous (IV) infusion on days 1, 3, 5, and 8.

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05769595

NCT05769595 | Single Dose Study of MK-2060 to Evaluate ...

The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of MK-2060 after a single dose intravenous ...

2.

merck.com

merck.com/news/merck-receives-fast-track-designation-from-the-u-s-fda-for-mk-2060-an-investigational-anticoagulant-therapy/

Merck Receives Fast Track Designation from the U.S. FDA ...

MK-2060 is a novel inhibitor of Factor XI being investigated for the prevention of thrombosis in patients with end-stage renal disease (ESRD).

3.

renalandurologynews.com

renalandurologynews.com/reports/factor-xi-arteriovenous-graft-thrombosis-rate-treatment-risk/

Inhibiting Factor XI Does Not Decrease Arteriovenous Graft ...

During a median follow-up of 16.6 months, the rate of first AVG thrombosis was 31.0% with high-dose MK-2060, 33.9% with low-dose MK-2060, and ...

4.

youtube.com

youtube.com/watch?v=AFtVEleHGmI

Phase 2B Trial of Efficacy and Safety of Factor XI Inhibition ...

MK 2060 did not significantly reduce the time to AV graft thrombosis compared to placebo and MK 2060 was associated with increased bleeding risk.

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S2666572724000130

The current landscape of factor XI inhibitors

The MK-2060-007 phase II study evaluates the efficacy (prevention of arteriovenous graft thrombosis as primary endpoint) and safety (adverse events and bleeding ...

6.

clinicaltrials.eu

clinicaltrials.eu/inn/mk-2060/

Mk-2060 – Application in Therapy and Current Clinical ...

Some of the potential side effects being watched for include: Bleeding events: Since MK-2060 affects blood clotting, there's a potential for increased bleeding.

7.

withpower.com

withpower.com/trial/phase-1-thrombosis-8-2024-d8d7d

MK-2060 Safety Study in Healthy Participants

These studies are designed to identify safe starting doses and monitor for any adverse effects, making the transition to human trials safer and more reliable.

8.

ctv.veeva.com

ctv.veeva.com/study/a-study-of-mk-2060-in-participants-with-chronic-kidney-disease-mk2060011

A Study of MK-2060 in Participants With Chronic and/or End ...

The purpose of Part 1 of the study was to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single subcutaneous dose ...